NSCLC Stage IIIB~IVPhase 2NCT04147351
A Phase II Study of Atezolizumab in Combination With Bevacizumab, Carboplatin or Cisplatin, and Pemetrexed for EGFR-mutant Metastatic Non-small Cell Lung Cancer Patients After Failure of EGFR Tyrosine Kinase Inhibitors.
A Phase 2 study testing Atezolizumab Injection; bevacizumab Injection in people with NSCLC Stage IIIB~IV, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
using Atezolizumab, a PD-L1 inhibitor, in combination with bevacizumab, platinum and pemetrexed to treat patients with EGFR mutated, advanced non-small cell lung cancer (NSCLC) after failure of EGFR tyrosine kinase inhibitors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- NSCLC Stage IIIB~IV
- What is being tested?
- Atezolizumab Injection; bevacizumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Apr 2020to 4 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage IIIB~IV NSCLC with known EGFR activating mutation not amenable to curative surgery or radiotherapy. EGFR activating mutations include exon19 deletion, L858R, G719X, L861Q, or S768I.
- Radiological documentation of disease progression following one or more lines of EGFR TKI treatment but have not received palliative chemotherapy.
- Patients must receive tumor EGFR genotyping in re-biopsied FFPE tumor samples.
- At least 20 years of age.
- World Health Organisation (WHO) performance status 0-2 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks
- At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline as ≥ 10mm in the longest diameter (except lymph nodes which must have short axis ≥ 15mm) with computed tomography (CT) or magnetic resonance imaging (MRI) which is suitable for accurate repeated measurements.
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- Normal bone marrow and organ function as defined below:
- Marrow: Hemoglobin ≥10gm/dL, absolute granulocyte count (AGC) ≥1500/mm3 platelets ≥100,000/mm3, absolute lymphocyte count ≥1000/mm3.
- Hepatic: Serum/plasma total bilirubin ≤1.5 x upper limit of normal (ULN) with the exception of <2.9 mg/dL for patients with Gilbert's disease, ALT (SGPT) and AST (SGOT) ≤2.5 x ULN.
- Renal: Serum/plasma creatinine (sCr) ≤1.5 x upper limit of normal, or creatinine clearance (Ccr) ≥45 mL/min.
- For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception that results in a low failure rate (< 1% per year) when used consistently and correctly, and to continue its use for 5 months after the last dose of atezolizumab and/or 6 months after the last dose of bevacizumab. Such methods include: combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation together with another additional barrier method always containing a spermicide, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence.
Who cannot join
- Previous exposure to platinum-based palliative chemotherapy. The treatment-free interval of neoadjuvant or adjuvant platinum-based chemotherapy should be more than 6 months before study enrollment is allowed
- Previous exposure to VEGF inhibitor for anti-cancer treatment
- Prior treatment with any other anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or an antibody targeting other immuno-regulatory receptors or mechanisms
- Patients carries EGFR genotype T790M or exon20 insertion should be excluded.
- Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of administration of atezolizumab.
- Expected to require any other form of antineoplastic therapy while on study
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- Patients with untreated symptomatic brain metastases. Patients with treated brain metastases will be allowed if brain imaging obtained greater than 7 days from trial enrollment reveals stable disease. Patients with small (< 3mm) asymptomatic brain metastasis are allowed to enroll. Patients on steroids doses higher than 10 mg of prednisone (or its equivalent) are excluded
- Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to study enrollment.
- Leptomeningeal disease
- Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for locoregional therapy, if appropriate, prior to study enrollment.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX®) are allowed.
- Malignancies other than NSCLC within 5 years prior to study enrollment, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous-cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
- On chronic systemic steroid therapy or on any other form of immunosuppressive medication
- Has received a live-virus vaccination within 30 days of planned treatment start
- Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, or abdominal carcinomatosis (known risks factors for bowel perforation)
- Severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
- Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapies for hormone deficiencies are allowed) (see Appendix V)
- Systemic cytotoxic chemotherapy, antineoplastic biologic therapy, or major surgery within 3 weeks of the first dose of study medication
- Active infection requiring therapy
- History of Human Immunodeficiency Virus (HIV) unless recent serology test is negative.
- Hepatitis B carrier: Patients with HBV infection were required to be receiving effective antiviral therapy and have a viral load less than 100 IU/mL at screening
- Active Hepatitis C
- Interstitial lung disease or pneumonitis requiring oral or IV glucocorticoids
- Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
- Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg). Anti-hypertensive therapy to achieve these parameters is allowable.
- History of hemoptysis (≥ one-half teaspoon of bright red blood per episode) within 1 month prior to study enrollment
- Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
Trial locations and contacts
1 site in 1 country.
About this study
using Atezolizumab, a PD-L1 inhibitor, in combination with bevacizumab, platinum and pemetrexed to treat patients with EGFR mutated, advanced non-small cell lung cancer (NSCLC) after failure of EGFR tyrosine kinase inhibitors.
Read the detailed description
Patients diagnosed with (i) stage IIIB~IV non-small cell lung cancer, (ii) tumor harbors activating mutation at EGFR, (iii) radiological confirmation of progressive disease with one or more lines of EGFR tyrosine kinase inhibitors but have not yet been exposed to palliative chemotherapy, will be eligible for screening procedure. The lung cancer stage will be determined according to the 8th edition of the International Association for the Study of Lung Cancer (IASLC) Tumor, Node, Metastasis (TNM) staging system for lung cancer.
In addition to screening of baseline bone marrow function, organ functions, and CT assessment of measurable target lesion(s), patients after TKI treatment failure must receive tumor EGFR genotyping by testing tumor DNA in re-biopsied tumor samples. Testing report from local laboratories will be accepted.
Enrollment of patients into the study will depend on EGFR testing results in re-biopsied tumor samples.
Duration induction phase, four cycles of atezolizumab 1200 mg will be administered over 60 min (1st cycle) and 30 min (2nd cycle onwards); bevacizumab 7.5mg/kg over 90 min in 1st cycle, 60 min in 2nd cycle and 30 min in 3rd cycle onward; pemetrexed 500 mg/m2 over 10 min; and cisplatin 75mg/m2 or carboplatin (CCr < 60) area under curve 5 mg/mL per min over 15-60 min intravenously every 3 weeks in the order listed.
Following the induction phase, patients will continue atezolizumab, bevacizumab and pemetrexed as maintenance therapy. Patients will continue treatment with bevacizumab and pemetrexed until progressive disease, unacceptable toxicity, or death. Patients may continue treatment with atezolizumab beyond radiographic progression by RECIST v1.1, provided they are experiencing clinical benefit as assessed by investigator (i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data, biopsy results [if available], and clinical status.
Atezolizumab and bevacizumab dose reduction will not be allowed. Modification of carboplatin or cisplatin, and pemetrexed doses will be done according to the local guidelines of National Taiwan University Hospital
- Conditions
- NSCLC Stage IIIB~IV
- Being tested
- Atezolizumab Injection; bevacizumab Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atezolizumab Injection; bevacizumab InjectionDrug
a PD-L1 inhibitor; anti-angiogenesis
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab+bevacizumab+pemetrexed+carboplatin or cisplatin | Experimental | Not described Receives: Drug: Atezolizumab Injection; bevacizumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The percentage of patients with radiologically complete or partial response as determined by the investigator according to RECIST version 1.1.
Measured: 9 MONTHS
Secondary outcomes (1)
Progression-free Survival (PFS)
PFS is measured from the date of study enrollment to radiographically documented progression according to RECIST 1.1 or death from any cause (whichever occurs first). Participants alive and without disease progression or lost to follow-up will be censored at the date of their last radiographic assessment.
Measured: about 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start10 Apr 2020
- Primary completion4 Feb 2026
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IIIB~IVStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147351
- Sponsor's protocol ID
- 201908090MIFA
- Status last verified
- Apr 2026
- First submitted
- 30 Oct 2019
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Atezolizumab in Combination With Bevacizumab, Carboplatin or Cisplatin, and Pemetrexed for EGFR-mutant Metastatic Non-small Cell Lung Cancer Patients After Failure of EGFR Tyrosine Kinase Inhibitors.
- ClinicalTrials.gov ID
- NCT04147351
- Acronym / sponsor ID
- 201908090MIFA
- Conditions
- NSCLC Stage IIIB~IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 4 Feb 2026 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
using Atezolizumab, a PD-L1 inhibitor, in combination with bevacizumab, platinum and pemetrexed to treat patients with EGFR mutated, advanced non-small cell lung cancer (NSCLC) after failure of EGFR tyrosine kinase inhibitors.
Detailed description
Patients diagnosed with (i) stage IIIB~IV non-small cell lung cancer, (ii) tumor harbors activating mutation at EGFR, (iii) radiological confirmation of progressive disease with one or more lines of EGFR tyrosine kinase inhibitors but have not yet been exposed to palliative chemotherapy, will be eligible for screening procedure. The lung cancer stage will be determined according to the 8th edition of the International Association for the Study of Lung Cancer (IASLC) Tumor, Node, Metastasis (TNM) staging system for lung cancer.
In addition to screening of baseline bone marrow function, organ functions, and CT assessment of measurable target lesion(s), patients after TKI treatment failure must receive tumor EGFR genotyping by testing tumor DNA in re-biopsied tumor samples. Testing report from local laboratories will be accepted.
Enrollment of patients into the study will depend on EGFR testing results in re-biopsied tumor samples.
Duration induction phase, four cycles of atezolizumab 1200 mg will be administered over 60 min (1st cycle) and 30 min (2nd cycle onwards); bevacizumab 7.5mg/kg over 90 min in 1st cycle, 60 min in 2nd cycle and 30 min in 3rd cycle onward; pemetrexed 500 mg/m2 over 10 min; and cisplatin 75mg/m2 or carboplatin (CCr < 60) area under curve 5 mg/mL per min over 15-60 min intravenously every 3 weeks in the order listed.
Following the induction phase, patients will continue atezolizumab, bevacizumab and pemetrexed as maintenance therapy. Patients will continue treatment with bevacizumab and pemetrexed until progressive disease, unacceptable toxicity, or death. Patients may continue treatment with atezolizumab beyond radiographic progression by RECIST v1.1, provided they are experiencing clinical benefit as assessed by investigator (i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data, biopsy results [if available], and clinical status.
Atezolizumab and bevacizumab dose reduction will not be allowed. Modification of carboplatin or cisplatin, and pemetrexed doses will be done according to the local guidelines of National Taiwan University Hospital
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab+bevacizumab+pemetrexed+carboplatin or cisplatin | Experimental | Drug: Atezolizumab Injection; bevacizumab Injection |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Stage IIIB~IV NSCLC with known EGFR activating mutation not amenable to curative surgery or radiotherapy. EGFR activating mutations include exon19 deletion, L858R, G719X, L861Q, or S768I.
- Radiological documentation of disease progression following one or more lines of EGFR TKI treatment but have not received palliative chemotherapy.
- Patients must receive tumor EGFR genotyping in re-biopsied FFPE tumor samples.
- At least 20 years of age.
- World Health Organisation (WHO) performance status 0-2 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks
Key exclusion criteria (27 listed)
- Previous exposure to platinum-based palliative chemotherapy. The treatment-free interval of neoadjuvant or adjuvant platinum-based chemotherapy should be more than 6 months before study enrollment is allowed
- Previous exposure to VEGF inhibitor for anti-cancer treatment
- Prior treatment with any other anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or an antibody targeting other immuno-regulatory receptors or mechanisms
- Patients carries EGFR genotype T790M or exon20 insertion should be excluded.
- Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of administration of atezolizumab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atezolizumab Injection; bevacizumab Injectiona PD-L1 inhibitor; anti-angiogenesis | Drug | Atezolizumab+bevacizumab+pemetrexed+carboplatin or cisplatin |
Primary outcome
Objective response rate (ORR)
Time frame: 9 MONTHS
The percentage of patients with radiologically complete or partial response as determined by the investigator according to RECIST version 1.1.
1 secondary outcome
Progression-free Survival (PFS)
Time frame: about 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab Injection; bevacizumab Injection in people with NSCLC Stage IIIB~IV, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 9 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.